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DrugVijoice® (alpelisib) [Novartis Pharmaceuticals Corporation]

October 2022

Therapeutic area - Enzyme Inhibitors, Systemic

Initial approval criteria

  • Patient is at least 2 years of age AND
  • Patient has a diagnosis of PIK3CA-related overgrowth spectrum (PROS), which includes fibroadipose hyperplasia, CLOVES syndrome, megalencephaly-capillary malformation syndrome, hemihyperplasiamultiple lipomatosis syndrome, hemimegalencephaly, and facial infiltrating lipomatosis AND
  • Patient has the presence of a PIK3CA-mutation as detected by a FDA-approved or CLIA-compliant test AND
  • Patient has severe and/or life-threatening manifestations of PROS (include, but are not limited to, overgrowth of various tissues, vascular malformations, kidney malformations, lymphatic malformations) AND
  • Patient must not have hypersensitivity to any component of Vijoice AND
  • Patient had a baseline fasting plasma glucose and HbA1c performed, and does not have diabetes mellitus type 1 or uncontrolled type 2 AND
  • Female patients of reproductive potential had a negative pregnancy test prior to initiating alpelisib AND
  • Female patients of reproductive potential and male patients with female partners of reproductive potential have been counselled on the use of effective contraception during alpelisib treatment and for 1 week after the last dose AND
  • Patient will not receive treatment in conjunction with other PI3K inhibitors (e.g., alpelisib [Piqray®], copanlisib [Aliqopa®], duvelisib [Copiktra®], idelalisib [Zydelig®]) AND
  • Patient will avoid coadministration with the following:
    • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s wort) AND
    • Breast cancer resistance protein (BCRP) inhibitors (e.g., ritonavir, imatinib, cyclosporin A), or if coadministration is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications
  • Initial approval is for 6 months

Renewal criteria

  • Patient must continue to meet the above criteria AND
  • Patient has not experienced any treatment-restricting adverse effects; examples include severe cutaneous reaction (Stevens-Johnson syndrome [SJS], erythema multiforme [EM], toxic epidermal necrolysis [TEN], and drug reaction with eosinophilia and systemic symptoms [DRESS]), pneumonitis/interstitial lung disease, severe hyperglycemia, severe diarrhea AND
  • Patient has disease response as defined by stabilization or decrease in lesion volume(s) in the absence of new lesions OR
  • Patient requires response optimization (clinical or radiological) AND
    • Patient is at least 6 years of age AND
    • Patient has received at least 24 weeks of therapy at 50 mg once daily
  • Renewal approval is for 12 months

Quantity limits

  • Pediatric patients (2 to less than 18 years of age): 50 mg once daily
  • Adult patients: 250 mg once daily


Vijoice is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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